Wed, Apr. 27, 4:18 PM
- Looking in the rear view mirror, author and New York Time columnist Randall Stross says the red flags were numerous surrounding discredited diagnostics firm Theranos and its relentlessly self-promoting chief Elizabeth Holmes.
- First, the company failed to elicit investments from the major Silicon Valley venture capital players despite numerous pitches/presentations. Professor Stross says it was turned down twice by GV (formerly Google Ventures) due to the apparent lack of substance (technical data) backing up its claims.
- Second, the company refused to publish in peer-reviewed journals, a tried-and-true way to credential the technology.
- Third, the make-up of the board was puzzling, since no member had experience in the diagnostics industry. Celebrity members, in this case former Secretary of State George Schultz and former National Security Advisor and Secretary of State Henry Kissinger, reinforced the perception that the constituency was for show instead of advancing the business.
- At least Ms. Holmes is famous, sporting the covers of Fortune, Forbes, Inc., and T: The New York Times Style Magazine. Maybe Rolling Stone is next.
- Diagnostics-related tickers: (NYSE:ABT)(OTCQX:RHHBY)(NYSE:TMO)
Wed, Apr. 20, 10:26 AM
- Point-of-care diagnostics firm Alere (ALR -6.9%) slumps on an 80% spike in volume in apparent response to comments made by Abbott Labs' (ABT -0.3%) Chairman Miles White during this morning's Q1 earnings call. When asked about his commitment to the $5.8B deal, announced in February, he deferred and said it would be inappropriate to comment on the transaction, citing Alere's delay in filing its 2015 annual report.
- Alere received a notice of non-compliance from the NYSE last month over the matter. The reason for the delay is an analysis of certain aspects of the timing of revenue recognition (cutoff) in Africa and China for the years 2013, 2014 and 2015. Per NYSE rules, the company has six months from March 15 to file the 10-K.
- Read now Abbott's Acquisition Of Alere May Lead To Value Destruction For Abbott Shareholders
Wed, Apr. 20, 8:39 AM
- Abbott Laboratories (NYSE:ABT) Q1 results ($M): Total Revenues: 4,885 (-0.2%); Nutrition: 1,671 (+0.1%); Diagnostics: 1,118 (+2.3%); Est. Pharmaceuticals: 888 (-1.0%); Medical Devices: 1,197 (-2.4%).
- Net Income: 316 (-86.2%); EPS: 0.21 (-86.1%); Non-GAAP EPS (continuing ops): 0.41 (-12.8%).
- 2016 Guidance: EPS: $1.36 - 1.46 from $1.55 - 1.65; Non-GAAP EPS: $2.14 - 2.16 from $2.10 to 2.20.
- The consensus view was EPS of $0.39 on revenues of $4.8B.
- Read now Why Long-Term Investors Should Consider Abbott Laboratories
Wed, Apr. 20, 7:48 AM
Tue, Apr. 19, 5:30 PM
Thu, Apr. 7, 4:39 PM
- Rumors doubting upstart blood tester Theranos' technology may be bit premature. The company recently hosted three scientific review sessions with leading experts who were invited to review its proprietary technologies with full access to its systems, devices and data. The group reviewed development and validation reports for tests performed on small volume samples, including finger-sticks, using Theranos' gear for a range of assays, including those chosen by the experts. They appear to have been favorably impressed.
- Co-chair of the company's Scientific and Medical Advisory Board David Helfet, M.D., director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital says, "It is clear that Theranos has done what people thought was impossible. Theranos invited groups of independent experts in the fields of pathology and laboratory medicine and literally took the lid off of the box. Experts were shown Theranos' technology, met with Theranos scientists and had access to any data. Theranos' technology is a ground-breaking feat of science and engineering, making it possible to accurately analyze micro amounts of blood for the same tests routinely done today with traditional venipuncture."
- After the three sessions, the company added eight prominent laboratory and medical experts to its Scientific and Medical Advisory Board. The group will advise company management and internal teams regarding the full integration of its technology into routine clinical practice. Those with laboratory management expertise will assist the company in inspecting its own labs and will help clinical lab directors implement best practices in their operations.
- Say what you will about the company and its "black box" technology, but it would not be possible to engage a large group of experts without technical credibility.
- Clinical diagnostics-related tickers: (NYSE:ABT)(OTCQX:RHHBY)(NYSE:TMO)
Wed, Mar. 30, 11:26 AM
- With the aim of maintaining the safety of the nation's blood supply, the FDA allows the use of Roche's (OTCQX:RHHBY) investigational test for the Zika virus to be used to screen donated blood in areas with active mosquito-borne transmission. The agency's decision should reduce the pressure on Puerto Rico, which has been importing blood from the continental U.S. after suspending local collections to reduce the risk of transmitting the virus to local patients.
- Per FDA guidance, local blood collections may resume if a licensed or investigational test for the Zika virus is available. The FDA's recommendations for Zika blood donor referrals remain in place.
- Related ticker: (ABT +0.5%)
- Update: Roche will roll out the test, performed on its automated cobas 6800/8800 systems, in Puerto Rico first, followed by sites in the southern U.S.
Tue, Mar. 15, 6:49 PM
- An FDA advisory panel has given unanimous support to a one-of-a-kind dissolving heart stent from Abbott Laboratories (ABT -1.5%).
- The "Absorb" stent is made to dissolve within three years of implantation, after it restores blood flow to a blocked artery. In a 9-0 vote, the FDA's panel decided the benefits of Absorb outweighed the risks, forecasting a likelihood of full FDA approval.
- Such a stent would eventually provide more natural artery motion in comparison with Abbott's market-leading Xience metal stent, which is permanently implanted.
- If approved, the new stent would compete with those made by competitors: Resolute, by Medtronic (MDT -0.9%), and Synergy and Promus, from Boston Scientific (BSX -1.3%). Wells Fargo has estimated that Absorb could initially capture about 5% of the drug-eluting stent market.
Wed, Feb. 24, 1:40 PM
- ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
- ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
- The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
- Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
- ViiV intends to advance cabotegravir to Phase 3 development later this year.
- Related tickers: (NASDAQ:GILD)(NYSE:ABT)(NYSE:BMY)(NYSE:JNJ)(NYSE:MRK)(OTCQX:RHHBY)
Fri, Feb. 19, 10:07 AM
Mon, Feb. 1, 8:07 AM
- Abbott Laboratories (NYSE:ABT) acquires point-of-care diagnostics firm Alere (NYSE:ALR) for $56 per share ($5.8B). The deal will be immediately accretive to earnings and is expected to add $0.12 - 0.13 to EPS in 2017 and more than $.20 in 2018. Annual pre-tax synergies should be ~$500M by 2019.
- Under the terms of the deal, Alere shareholders will receive $56 per share in cash. Abbott will also assume $2.6B in Alere outstanding debt.
- Waltham-MA-based Alere generates ~$2.5B in sales per year. Shares are up 46% premarket on light volume.
Thu, Jan. 28, 8:17 AM
- Abbott Laboratories (NYSE:ABT) Q4 results ($M): Total Revenues: 5,188 (-3.1%); Nutrition: 1,800 (-0.2%); Diagnostics: 1,220 (-1.1%); Est. Pharmaceuticals: 885 (-4.0%); Medical Devices: 1,297 (-5.9%).
- Net Income: 767 (-15.2%); EPS: 0.51 (-13.6%); Non-GAAP EPS (continuing ops): 0.62 (0.0%).
- 2016 Guidance: EPS: $1.55 - 1.65; Non-GAAP EPS: $2.10 - 2.20.
- Q1 Guidance: EPS: $0.23 - 0.25; EPS ex-items: $0.38 - 0.40.
- Shares are down 4% premarket on light volume.
Thu, Jan. 28, 7:41 AM
- Abbott Laboratories (NYSE:ABT): Q4 EPS of $0.62 beats by $0.01.
- Revenue of $5.19B (-3.2% Y/Y) misses by $80M.
Wed, Jan. 27, 5:30 PM
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Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 27, 1:13 PM
- Tomorrow is a busy day for healthcare large caps with six firms reporting Q4 results. Companies and consensus views are:
- Premarket: Eli Lilly (LLY +1.1%): EPS of $0.78 on revenues of $5.3B; Zimmer Biomet Holdings (ZBH +1.1%): EPS of $2.04 on revenues of $2.0B; Abbott Laboratories (ABT +2.3%): EPS of $0.61 on revenues of $5.3B; Celgene (CELG -1%): EPS of $1.22 on revenues of $2.5B and Bristol-Myers Squibb (BMY -0.5%): EPS of $0.28 on revenues of $4.1B.
- After the close: Amgen (AMGN): EPS of $2.29 on revenues of $5.5B.
Abbott Laboratories engages in the discovery, development, manufacture and sale of a broad and diversified line of health care products. The company operates through four reportable segments: Established Pharmaceutical Products, Diagnostic Products, Nutritional Products and Vascular Products.... More
Industry: Drug Manufacturers - Major
Country: United States
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